This clinical trial is focused on studying Crohn’s Disease, a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The study will evaluate the effectiveness and safety of a new oral medication called Zasocitinib, also known by its code name TAK-279. Participants in the study will receive either Zasocitinib or a placebo, which is a substance with no active medication, to compare the outcomes.
The purpose of the study is to assess how well Zasocitinib works in reducing the symptoms of Crohn’s Disease. The study will last for a period of 52 weeks, during which participants will take the medication in capsule form. The main goal is to see if the medication can help achieve an improvement in the condition by Week 12. Participants will undergo regular check-ups and assessments to monitor their progress and any changes in their symptoms.
Throughout the study, participants will be closely monitored to ensure their safety and to gather information on how the medication affects their health. The study aims to provide valuable insights into the potential benefits of Zasocitinib for individuals with moderately to severely active Crohn’s Disease, contributing to the development of more effective treatments for this challenging condition.
1joining the study
Upon joining the study, the participant will be required to provide informed consent. This involves signing a document that confirms understanding of the study procedures and requirements.
Eligibility will be confirmed based on specific criteria, including age and a diagnosis of moderately to severely active Crohn’s disease.
2screening period
During the screening period, the participant will undergo an ileocolonoscopy with biopsies to confirm the diagnosis of Crohn’s disease.
Additional assessments may include a review of medical history and previous treatments for Crohn’s disease.
3randomization and treatment
Participants will be randomly assigned to receive either the study medication, zasocitinib, or a placebo. Both are administered in capsule form.
The medication is taken orally. The specific dosage and frequency will be determined by the study protocol.
4treatment duration
The treatment will continue for a period of 12 weeks. During this time, the participant will be monitored for any changes in their condition.
5end of treatment assessment
At the end of the 12-week treatment period, an assessment will be conducted to evaluate the response to the medication.
This includes an endoscopic examination to measure any changes in the severity of Crohn’s disease.
6follow-up
After the treatment period, follow-up assessments will be conducted to monitor the participant’s health and any long-term effects of the treatment.
Who Can Join the Study?
The person must be willing and able to understand and follow the study procedures and requirements, including using digital tools and applications. They must also provide written consent before starting any study procedures.
The person must be between 18 and 75 years old at the time of signing the consent form. In South Korea, the minimum age is 19 years.
The person must have active moderate to severe Crohn’s Disease (CD) affecting specific parts of the intestine, confirmed by a score called CDAI between 220 and 450 and the presence of ulcers seen during a procedure called ileocolonoscopy.
The person must have a confirmed diagnosis of CD for at least 30 days before screening. This includes a biopsy report confirming the diagnosis and a report showing how long they have had the disease based on previous ileocolonoscopy.
If the person has a family history of colorectal cancer, is over 50 years old, or has other risk factors, they must be up to date with colorectal cancer checks, which can be done during screening.
The person must be willing and able to undergo an ileocolonoscopy with biopsies during screening after meeting all other criteria.
The person must have a history of not responding well, losing response, or not tolerating certain treatments for CD. This includes medications like 6-mercaptopurine, azathioprine, corticosteroids, or biologic agents like TNF antagonists.
If the person can have children and is sexually active, they must agree to use effective birth control during the study and for 10 days after the last dose of the study drug. Women must be surgically sterile, not able to have children, or use a highly effective method of contraception if sexually active with a non-sterilized partner.
Who Cannot Join the Study?
Patients who have other serious health conditions that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had recent surgery related to Crohn’s Disease.
Patients who have a history of not following medical advice or treatment plans.
Patients who are pregnant or breastfeeding.
Patients who have a known allergy to the study medication or similar drugs.
Patients who have used certain medications that might affect the study results.
Patients who have a history of alcohol or drug abuse.
Patients who have an active infection that requires treatment.
Patients who have a history of cancer, except for certain types of skin cancer.
TAK-279 is an experimental medication being studied for its potential to help people with moderately to severely active Crohn’s Disease. This medication is taken by mouth and is being tested to see if it can improve the condition of the intestines as seen through an endoscope, which is a special camera used to look inside the body. The goal is to see if TAK-279 can help reduce the symptoms and inflammation associated with Crohn’s Disease over a 12-week period.
Crohn’s Disease – Crohn’s Disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of active symptoms and remission. During active phases, individuals may experience abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications such as strictures or fistulas. The disease can vary in severity, with some people experiencing mild symptoms and others having more severe manifestations. The exact cause is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors.
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